| CTRI Number |
CTRI/2024/06/068937 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Platelet Rich Fibrin, Platelet Rich Plasma and mineral trioxide aggregate as pulpotomy agents in primary mandibular molars |
|
Scientific Title of Study
|
Comparative evaluation of Platelet Rich Plasma, Platelet Rich Fibrin and Mineral Trioxide Aggregate as pulpotomy agents in primary molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Kumar |
| Designation |
Post graduate Student |
| Affiliation |
UCMS & GTBH Dilshad Garden Delhi 110095 |
| Address |
Department of Dentistry
Unit 1
Deprartment of Pediatric and Preventive Dentistry
UCMS & GTBH
Dilshad Garden
Delhi 110095
North East
DELHI
110095
India |
| Phone |
8628969967 |
| Fax |
|
| Email |
pirthiaman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishi Tyagi |
| Designation |
Professor |
| Affiliation |
UCMS & GTBH Dilshad Garden Delhi 110095 |
| Address |
Department of Dentistry
Unit 1
Deprartment of Pediatric and Preventive Dentistry
UCMS & GTBH
Dilshad Garden
Delhi 110095
North East
DELHI
110095
India |
| Phone |
986857552 |
| Fax |
|
| Email |
tyagi_rishidoc@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aman Kumar |
| Designation |
Post graduate Student |
| Affiliation |
UCMS & GTBH Dilshad Garden Delhi 110095 |
| Address |
Department of Dentistry
Unit 1
Deprartment of Pediatric and Preventive Dentistry
UCMS & GTBH
Dilshad Garden
Delhi 110095
North East
DELHI
110095
India |
| Phone |
8628969967 |
| Fax |
|
| Email |
pirthiaman@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrAman Kumar |
| Address |
Department of Dentistry
Unit 1
Dpartment of Peditric and Preventive Dentistry
UCMS GTBH
Dilshad Garden
Delhi 110095 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAman Kumar |
University college of medical sciences and GTB Hospital |
Department of dentistry University college of medical sciences and GTB Hospital Dilshad garden
East
DELHI |
8628969967
Pirthiaman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI – 110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mineral trioxide aggregate |
Mineral trioxide aggregate is control and will be used for comparison between the groups studied for 9 Months |
| Intervention |
Platelet RichFibrin, Platelet Rich Plasma |
Pulpotomy on Patient will be done with Platelet Rich Fibrin and Platelet Rich Plasma and will be followed up for a period of 9 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children in age group of 4-8years. 2. Patient compliance with treatment. 3. No spontaneous or nocturnal pain and tenderness to percussion. 4. Caries removal results in pulp exposure with normal pulp or reversible pulpitis. 5. Ease of hemorrhage control post access-opening and excavation from amputated pulp stumps. |
|
| ExclusionCriteria |
| Details |
1. Existence of spontaneous pain or nocturnal pain, with clinical signs or symptoms of pulp degeneration (swelling, abscess, fistula, pathologic mobility). 2. Caries penetrating the floor of pulp chamber. 3. Radiographic evidence of teeth with internal resorption. 4. Teeth with physiologic resorption of root not more than one third with restorable remaining tissue. 5. Presence of inter-radicular bone loss. 6. Tooth close to natural exfoliation. 7. Teeth with developmental defects. 8. Children with special health care needs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Clinical comparison of Platelet Rich Plasma, Platelet Rich Fibrin and mineral trioxide aggregate as a pulpotomy agents in primary molars |
Over a period of 3,6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Radiographic comparison of Platelet Rich Plasma, Platelet Rich Fibrin and mineral trioxide aggregate as a pulpotomy agents in primary molars |
Over a period of 3,6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients will be recruited from the outpatient settings of Department of Dentistry (Unit of Pedodontics and Preventive Dentistry), University College of Medical Sciences and Guru Teg Bahadur Hospital. All healthy children having carious primary molars in mandibular arch, satisfying inclusion and exclusion criteria will be included in the study. In the study there will be total of 60 carious teeth, which will be allocated to three groups using simple randomization method. The study will consist of three groups: Group 1: Platelet Rich Plasma Group 2: Platelet Rich fibrin Group 3: Mineral Trioxide Aggregate A sample of 60 carious teeth will be treated with standardized pulpotomy procedure, dividing it into three groups of 20 carious teeth in each group. Clinical evaluation for pain, swelling, and tenderness to percussion will be done at 24 hours, and after every 1, 3, 6 and 9 months. The radiographic evaluation included: periodontal space widening, internal resorption, periapical radiolucency and furcation radiolucency will be assessed in 3, 6 and 9 months respectively. |